Midazolam maleate
Buccolam, Midazolam, Midozalam, Nayzilam, Seizalam (midazolam maleate) is a small molecule pharmaceutical. Midazolam maleate was first approved as Versed on 1985-12-20. It is used to treat anxiety disorders, psychomotor agitation, and status epilepticus in the USA. It has been approved in Europe to treat epilepsy.
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Commercial
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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FDA
EMA
Brand Name
Status
Last Update
midazolamANDA2024-12-26
midazolam hclunapproved drug other2016-04-06
midazolam hydrochlorideANDA2025-03-24
midazolam in sodium chlorideANDA2025-01-31
mkh dose packunapproved drug other2019-03-05
mko melt dose packunapproved drug other2019-03-04
n/aNew Drug Application2024-05-09
nayzilamNew Drug Application2023-01-19
seizalamNew Drug Application2023-01-26
versed guards up daily mineral sunscreen broad spectrum spf 35OTC monograph final2022-08-30
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Indications
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Agency Specific
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EMA
Expiration
Code
MIDAZOLAM, NAYZILAM, UCB INC
2026-05-17ODE-243
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT
2025-09-14ODE-207
Patent Expiration
Patent
Expires
Flag
FDA Information
Midazolam, Midazolam In 0.9% Sodium Chloride, Inforlife
109669902038-06-20DP
Midazolam, Nayzilam, Ucb Inc
82170332028-01-18DPU-2526
88093222028-01-18DP
92894322028-01-18DPU-2526
96874952028-01-18DPU-2526
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05C: Hypnotics and sedatives
N05CD: Benzodiazepine derivative hypnotics and sedatives
N05CD08: Midazolam
HCPCS
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Clinical
Clinical Trials
1555 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients1861126196
AnesthesiaD000758427192454
Postoperative painD010149G89.18364152650
NeoplasmsD009369C8034322847
DepressionD003863F33.991597842
DeliriumD003693R41.0513151741
AnxietyD001007EFO_0005230F41.1162131839
Depressive disorderD003866EFO_1002014F32.A81378738
PainD010146EFO_0003843R5273101333
Anxiety disordersD001008EFO_0006788F41.1242101532
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Indications Phases 3
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
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Total
Drug interactionsD00434727330
PsoriasisD011565EFO_0000676L401111
ArthritisD001168EFO_0005856M05-M14617
OverweightD050177E66.366
Rheumatoid arthritisD001172EFO_0000685M06.966
Colorectal neoplasmsD015179145
Sickle cell anemiaD000755EFO_0000697D57415
MelanomaD00854544
Hepatitis cD006526B19.244
Cystic fibrosisD003550EFO_0000390E8444
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiopulmonary bypassD00231544
AgingD000375GO_0007568R41.8133
TachycardiaD013610R00.033
Airway managementD05810933
Epidural analgesiaD01536022
Aortic dissectionD000784I71.022
Thoracic surgical proceduresD01961622
Anterograde amnesiaD020324R41.122
Intraoperative awarenessD05892622
Gastrointestinal microbiomeD00006919622
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMidazolam maleate
INNmidazolam
Description
Midazolam is an imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. It has a role as a GABAA receptor agonist, an anticonvulsant, an anxiolytic drug, an apoptosis inducer, an antineoplastic agent, a muscle relaxant, a sedative, a general anaesthetic and a central nervous system depressant. It is an organochlorine compound, an imidazobenzodiazepine and a member of monofluorobenzenes.
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Classification
Small molecule
Drug classBenzodiazepine
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Structure (InChI/SMILES or Protein Sequence)
Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2.O=C(O)/C=C\C(=O)O
Identifiers
PDB
CAS-ID59467-70-8
RxCUI6960
ChEMBL IDCHEMBL2106922
ChEBI ID
PubChem CID4192
DrugBankDB00683
UNII IDR60L0SM5BC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 56,088 documents
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Safety
Black-box Warning
Black-box warning for: Midazolam, Midazolam hydrochloride, Midazolam in sodium chloride, N/a, Nayzilam, Seizalam
Adverse Events
Top Adverse Reactions
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14,929 adverse events reported
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